French diagnostics company bioMérieux (Euronext Paris:BIM) announced on Wednesday that it has secured US Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver for its BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini.
This point-of-care test detects five common respiratory pathogens in 15 minutes, aiding faster diagnoses.
The approval caters to the growing demand for rapid diagnostics outside hospital labs, particularly in emergency departments and urgent care settings. The Panel Mini complements bioMérieux's existing, broader R/ST Panel, offering healthcare providers flexibility based on patient needs.
Expected for US release in Q3 2024, the Panel Mini strengthens bioMérieux's foothold in the North American outpatient market.
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